1. Field of the Invention
The present invention relates generally to an apparatus for collecting, processing and analyzing a liquid specimen in a fully integrated system. This invention also relates to a method for collecting, processing, and analyzing a liquid specimen.
2. Description of the Related Art
Diagnostic testing throughout the world is currently carried out using a variety of different specimen types. Many of the samples tested, such as whole blood, serum, oral fluid, plasma, cerebrospinal fluid and others, are liquid.
Testing for infectious diseases under laboratory conditions typically involves use of a blood serum specimen obtained by removing the blood cells from an intravenous blood sample by centrifugation. The sample is first drawn from the patient by a trained phlebotomist. The serum sample so obtained is then tested under laboratory conditions using one of a number of methodologies, such as Enzyme Linked Immuno Sorbent Assay (ELISA), Immunofluorescence (IFA), Latex Agglutination (LA), or any of a number of automated instrument platforms employing chemiluminescence, fluorescence or other sensitive technologies. As there are other known diagnostic technologies in place, this is by no mean an exhaustive list.
Although serum testing under laboratory conditions has traditionally constituted the technique of choice, there is now a growing trend to move testing closer to the patient and use alternative specimen matrices such as whole blood and others. In other words, the sample is drawn from the patient, processed and analyzed more rapidly, often while the patient is still in attendance. The recent advance known as “near-patient” or “point-of-care” testing has caused a major shift in the way testing is done. Statistics show growth of over 20% per annum in this mode of testing for each of the last four years.
Such growth in this mode of testing has resulted in the increased use of alternate specimen types (e.g. whole-blood or oral fluid) not requiring the use of trained phlebotomists or additional steps to separate red blood cells from the required specimen. Rather, the sample can be drawn from the patient and processed directly. As a consequence, results can now be obtained, analyzed and conveyed to the patient while the patient or subject is still in the presence of the healthcare provider. This avoids the need for repeat patients or the need for the patient to contact the healthcare provider at a future time to obtain their test results.
Point-of-care (POC) testing therefore offers the advantage of giving the physician (and, if the physician chooses, the patient) immediate results, in contrast to conventional testing, where there is a waiting period, that could be anywhere from several hours to weeks, during which the specimens are transported to a laboratory testing facility, processed, and results sent to the physician.
It is standard in the industry to confirm infectious disease test results by repeat testing, often by a more sensitive methodology, especially when the testing is for potentially life-threatening diseases such as HIV, Hepatitis C, Hepatitis B, and so on. This applies regardless of whether the testing is performed in a laboratory or at the point-of-care. The second test used to confirm the result of the primary test is known as a “confirmatory” or “confirmation” test and typically uses a different methodology to confirm a diagnosis or otherwise. For instance in HIV diagnostics, Western Blot or ELISA methods may be used. In all instances a second specimen will be required. Owing to the serious nature of such testing, anything that can expedite sample processing is of tremendous importance.
In the case of laboratory testing, there may be sufficient specimen material remaining from the initial blood draw to carry out confirmation testing.
However, no rapid (in-office) tests are known which include a mechanism to collect a specimen for confirmatory testing at the time of the first patient visit to the healthcare facility.